Clinical Study: Analysis of Glycemic Control and Satisfaction With a Connected Smart Cap in Patients With Type 1 Diabetes Mellitus

NCT ID: NCT06845891

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-26
• Study Completion Date: 2025-06-19

Brief Summary

This clinical study evaluates the impact of the Cap INSULCLOCK device on glycemic control, treatment adherence, and patient satisfaction in adults with type 1 diabetes mellitus (T1DM). Despite advances in pharmacology and technology, a significant proportion of individuals with T1DM fail to achieve recommended glycemic targets, partly due to the complexity of insulin therapy and suboptimal adherence. Cap INSULCLOCK is a device that attaches to insulin pens, automatically recording injections and integrating data on glucose levels, insulin administration, food intake, and physical activity, with real-time Bluetooth transmission. Its use may enhance adherence and optimize metabolic control.

This study is a randomized, low-intervention clinical trial conducted at a single center, enrolling 42 patients, who will be randomized into two groups: one using the activated device and a control group using the device in a blinded mode. The primary objective is to assess differences in time above range (TAR >180 mg/dL) over the last 14 days of continuous glucose monitoring (CGM). Secondary objectives include evaluating HbA1c levels, time in range (TIR), frequency of hypoglycemic episodes, and patient satisfaction. Data will be analyzed using advanced statistical methods, and the intervention is expected to improve adherence, reduce glycemic variability, and enhance quality of life in individuals with T1DM

Conditions

Type 1 Diabetes Mellitus; Type 1 Diabetes Mellitus (T1DM); Diabetes Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Connected smart cap

This arm will have access to the cap, which is connected to the digital application that records the timing of insulin injections and provides reminders in case of missed doses.

Group Type: EXPERIMENTAL

CONNECTED SMART CAP

Intervention Type: DEVICE

The intervention in this study consists of attaching a smart cap to the insulin pen of individuals with type 1 diabetes who use flash glucose monitoring and experience a time above range (TAR \>180 mg/dL) for more than 25% of the time. This metric has been associated with diabetes-related complications, and the objective of this study is to determine whether this simple device could help reduce this underexplored parameter.

cap disconnected

This treatment arm will receive the cap without connectivity, thereby lacking access to the information provided by the digital application, including the timing of insulin injections, injection events, and reminder notifications.

Group Type: ACTIVE_COMPARATOR

CONNECTED SMART CAP

Intervention Type: DEVICE

The intervention in this study consists of attaching a smart cap to the insulin pen of individuals with type 1 diabetes who use flash glucose monitoring and experience a time above range (TAR \>180 mg/dL) for more than 25% of the time. This metric has been associated with diabetes-related complications, and the objective of this study is to determine whether this simple device could help reduce this underexplored parameter.

Interventions

CONNECTED SMART CAP

The intervention in this study consists of attaching a smart cap to the insulin pen of individuals with type 1 diabetes who use flash glucose monitoring and experience a time above range (TAR \>180 mg/dL) for more than 25% of the time. This metric has been associated with diabetes-related complications, and the objective of this study is to determine whether this simple device could help reduce this underexplored parameter.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Men and women aged 18 years or older.
• Diagnosis of type 1 diabetes mellitus (T1DM).
• Users of flash continuous glucose monitoring (FGM) sensors with >70% of recorded data, including intake and insulin dose logs.
• Adequate therapeutic adherence, with no missed appointments in the past year.
• Time above range (TAR >180 mg/dL) >25%.
• Ability to provide informed consent to participate in the study.
• Access to technology for follow-up, including a smartphone with internet connectivity and compatibility with the Insulcloud app.

Exclusion Criteria

• Current pregnancy.
• Severe acute illness.
• Inability to provide informed consent or to meet the study requirements for any reason.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fernando Sebastián Valles

OTHER

Sponsor Role: lead

Responsible Party

Fernando Sebastián Valles

Medical doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Universitario de La Princesa

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

5350

Identifier Type: REGISTRY

Identifier Source: secondary_id

5350

Identifier Type: -

Identifier Source: org_study_id